CytoDyn Completes FDA Meeting on Phase II Leronlimab Study for Relapsed/Refractory MSS Colorectal Cancer

On August 12, 2024, CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology firm specializing in the development of leronlimab, a CCR5 antagonist with multiple potential therapeutic applications, announced a significant milestone. The Company recently held a meeting with the U.S. Food and Drug Administration (FDA) to discuss the rationale and proposed dosing for its upcoming Phase II study. This trial aims to evaluate the preliminary safety and efficacy of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in patients with CCR5+, microsatellite stable (MSS), and relapsed or refractory metastatic colorectal cancer (mCRC).

Following the meeting, CytoDyn plans to submit its final study protocol to the FDA. They will also engage a clinical research organization (CRO) and undertake other preparatory activities necessary to initiate the trial.

This open-label, randomized (1:1), multicenter trial will assess the anti-tumor activity, specifically the overall response rate (ORR), of leronlimab at doses of 350 mg and 700 mg in combination with TAS-102 and bevacizumab. The study will involve approximately 60 patients with CCR5+, MSS metastatic CRC. Participants in the trial must have measurable disease as per RECIST v1.1 and have previously undergone treatment with fluoropyrimidine‐, oxaliplatin‐, and irinotecan‐based chemotherapy. Additionally, they should have received an anti‐VEGF therapy and, if RAS wild‐type and medically appropriate, an anti-EGFR therapy as well. The presence of CCR5 tumor expression will be confirmed using an immunohistochemistry assay (IHC), and the diagnosis of MSS CRC will be verified through IHC or next-generation sequencing (NGS).

In the trial, TAS-102 and bevacizumab will be given over three out of four weeks in a four-week cycle, with leronlimab administered weekly at the specified doses. The study will begin with a safety lead-in phase, where five patients will receive the 350 mg dose of leronlimab. Following this, enrollment for the 700 mg dose group will commence.

Dr. Jacob Lalezari, CEO of CytoDyn, expressed satisfaction with the FDA's feedback on the Phase II study. "We are pleased to have received the FDA’s feedback on our Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer and remain on track to commence our oncology trial in the coming months," he said. He emphasized that advancing leronlimab in oncology is a critical priority for the team as they continue to develop CytoDyn’s clinical pipeline.

CytoDyn is a clinical-stage biotechnology company that focuses on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb). Leronlimab is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is implicated in various disease processes. CytoDyn is exploring the therapeutic potential of leronlimab in a range of areas, including oncology and inflammation.

The company's efforts reflect its commitment to advancing innovative treatments that address unmet medical needs, particularly in the realm of cancer therapy. By pushing forward with this trial, CytoDyn aims to provide new hope for patients with challenging forms of colorectal cancer.